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DOI: 10.1055/s-0040-1704290
WATS3D FOR THE DETECTION OF HIGH GRADE DYSPLASIA AND ADENOCARCINOMA IN BARRETT: EUROPEAN MULTI-CENTER, PROSPECTIVE, RANDOMIZED, TANDEM STUDY
Publication History
Publication Date:
23 April 2020 (online)
Aims To compare the independent additional yield for HGD/EACs diagnosis resulting from WATS versus 4 quadrant random forceps biopsy (RFB) in a multicenter setting.
Methods Patients with known BEdysplasia following resection of visible lesions scheduled for ablation therapy at 15 European centers were 1:1 randomized to WATS followed by RFB or vice versa. All WATs were examined with computer assistance by an experienced pathologist (FF) at CDx; all RFBs were examined by a single expert pathologist (GD), blinded to clinical information. Primary endpoints were the detection rate of HGD/AC and the incremental detection attributable to WATS over RFB. Secondary endpoints were detection rate of HGD/AC for the two procedures in combination, detection rate of HGD/AC according to the order of WATS sample acquisition (i.e., before or after RFB acquisition) and procedural times.
Results 147 patients (male/female, 123/24; mean age, 68.4 years) were included. Overall, we found 49 HGD/EAC cases. Of these, 25 were detected with both modalities, 14 were detected solely by WATS but missed by RFB and 10 solely by RFB but missed by WATS. The detection rate of HGD/EACs did not differ between WATS (39/147) and RFB (35/147) (26.5%, 95% CI:19.6-34.4% vs 23.8%, 95% CI:17.2-31.5%); p=0.541). Integrated WATS and RFB (49/147) significantly improved detection of HGD/EACs vs RFB alone (33.3%, 95% CI:25.8-41.6%; p< 0.001). The mean procedural time for RFB alone, WATS alone and integrated WATS and RFB were 6.4 (95% CI:5.8-7.2; median, 5.0; IQR,4-8) minutes, 4.8 (95% CI:4.1-5.5; median, 5.0; IQR, 3-6) minutes and 11.2 (95% CI:10.5-11.9; median, 10; IQR, 8-14) minutes, respectively.
Conclusions In an enriched population with known dysplasia, WATS and RFB detected similar number of cases with HGD/EAC. However, the combination of the two techniques significantly improved detection of HGD/EAC compared to RFB alone, confirming the role of WATS as an adjunct to RFB.
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